FDA Inspection
FORDOZ PHARMA CORPORATIONFORDOZ PHARMA CORPORATION – FDA Inspection, Nov 12, 2025
Record Details
This FDA Inspection record concerns FORDOZ PHARMA CORPORATION, with an inspection on November 12, 2025, issued by the New Jersey District Office, covering human drugs.
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ID · f74f11d4-45af-4ab0-a6c7-ad42a05f6193
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1291050
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)input/output verification
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Other FDA inspections of FORDOZ PHARMA CORPORATION
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2023 | VAI | New Jersey District Office |
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